Thiamine as a Metabolic Resuscitator in Septic Shock

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of shock.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institutes of Health (NIH)
• Treatments: Thiamine

Criteria

Inclusion Criteria:

• Greater than 18 years old

• Suspected or confirmed source of infection

• Hypotension (systolic pressure <90 mmHg) after a minimum 2 liter fluid bolus followed by vasopressor-dependence.

• Lactic Acidosis > 3 mmol/dl

Exclusion Criteria:

• Competing cause of lactic acidosis including: seizures within 3 hours of enrollment, use of linazolid metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders

• Liver dysfunction specifically defined as AST or ALT elevation greater than 240

• Current Thiamine supplements or usage

• Competing indication for thiamine administration

• Cardiac Arrest

• DNR/DNI or comfort care status (DNR status in an intubated patient receiving full care is eligible)